Glossary

Aberrant S-Phase Induction: Deviating from the usual or normal progression into the S-Phase (synthesis phase where dna/chromosome replication occurs) of the cell cycle. The BD ProEx™ C Antibody Cocktail is highly sensitive and specific to aberrant S-Phase induction.

Abnormal Pap Test: A Pap test in which precancerous or cancerous cells are identified; also referred to as a positive Pap test.

Accessioning of Slides: The procedure through which a Pap test is given an identifying number at the laboratory.

Adenocarcinoma: A malignant tumor arising from glandular epithelial tissue that lines organs, such as the lungs, intestines and cervix.

Adjunctive: Joined or added to another, but not necessarily a part of it (e.g. ICC adjunctive cytology diagnosis- BD ProEx™ C ICC test result is adjunctive to the Pap result to provide additional diagnostic information).

Algorithm: A step-by-step problem solving procedure, especially an established procedure with a finite number of steps.

Analyte Specific Reagent (ASR): Antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acids sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a lab validated diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.

Anatomical Pathology: The study of organs and tissues removed from the body.

Antibody (Ab): An immunoglobulin molecule that has a specific amino acid sequence by virtue of which it interacts only with the antigen that induced its synthesis in cells of the lymphoid series or with an antigen closely related to it.

Antigen (Ag): Any substance which is capable, under appropriate conditions, of inducing a specific immune response and of reacting with the products of that response.

Apoptosis: Cell death; Fragmentation of a cell into membrane-bound particles that are then eliminated by phagocytosis.

Atypical Squamous Cells of Undetermined Significance (ASCUS): A condition where normal cells are present, but the potential growth development is unclear.

Bethesda System: A reporting system for cervical/vaginal cell specimens (Pap tests) developed at the National Cancer Institute in December 1988 and re-evaluated in 1991; based on a descriptive diagnosis and evaluation of specimen adequacy.

Buffer: A buffer is a substance capable in solution of neutralizing both acids and bases to maintain the original acidity or basicity of the solution.

Cell Cycle: Sequence of events at the cellular level during which cell reproduction occurs. Cell reproduction entails replication of the DNA (S-Phase) followed by division of the nuclear components and partitioning of the cytoplasm into two daughter cells (M-Phase).

Cell Cycle Checkpoint: Mechanism by which the cell actively halts progression through the cell cycle until it can ensure that an earlier process, such as DNA replication or mitosis, is complete. G1 and G2 are the two cell cycle checkpoints.

Cervical Biopsy: Removal of a small piece of living tissue from the cervix, which is then sent to a laboratory for microscopic evaluation.

Cervix: The lower, narrow end of the uterus.

Chromosome: In animal cells, a structure in the nucleus containing a linear thread of DNA, which contains and transmits genetic information and is associated with RNA and histones.

CLIA (Clinical Laboratory Improvement Amendment): Law establishing quality standards for all laboratory testing (except research) to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test is performed. Lab tests are categorized as waived testing, moderately complex, and highly-complex. Laboratories performing these tests must meet certain criteria to perform tests in a particular category.

Clinical Laboratory Improvement Amendments of 1988 (CLIA '88): Amendment to federal legislation passed to improve quality control at cytology laboratories; under CLIA '88, the number of slides a cytotechnologist may screen each day is regulated and quality control procedures require rescreening of a minimum of 10% randomly selected within-normal-limits (WNL) slides per day.

Clinical Pathology: Laboratory medicine that includes analysis of specimens such as urine and blood.

Colposcopic Examination: Inspection of the cervix by a healthcare professional with a microscope (colposcope) that magnifies the cervix eight to thirty times; used to identify the location, size and area of abnormal cells of the cervix.

Cyto (cyt): prefix; meaning cell.

Cytochemistry: The study of the chemical composition of cells.

Cytology: The study of cells; their origin, structure, and function.

Cytopathologist: A medical doctor skilled in anatomical or clinical pathology who subspecializes in cytopathology; the medical doctor trains for an additional three to five years after medical school to become board-certified in both pathology and cytopathology (the science by which the health of cells is interpreted and diagnosed).

Cytoplasm: A colloidal viscous matrix that is external to the nucleus in a cell. The protoplasm of a cell, excluding the nucleus.

Cytotechnologist: Trained individuals who identify cellular abnormalities in cytology laboratories; graduate of an accredited school of cytotechnology who then successfully complete board certification examination with the American Society of Clinical Pathologists (ASCP) Board of Registry; all hold a bachelor's degree. Cytotechnology is the practice of reviewing cells on slides.

Diagnosis: The act or process of identifying or determining the nature and cause of disease or injury through evaluation of patient history, examination and review of laboratory data.

Diagnostic device: An instrument or test used in medical diagnosis.

Differentiate: To become distinct or specialized; acquire a different character. Cells differentiate during development to become specialized in structure and function.

DNA (Deoxyribonucleic Acid): The genetic material of all cellular organisms. Genetic material is replicated during the S-Phase of the cell cycle.

Dysplasia: A benign but possibly precancerous condition that occurs when normal cells on the cervical surface are replaced by a layer of abnormal cells; in pathology alteration in size, shape and organization of adult cells. Dysplasia is defined in morphological terms by a loss of normal orientation of epithelial cells, accompanied by alterations in cellular and nuclear size, shape and staining characteristics.

Epithelial: Cells forming the covering of most internal and external surfaces of the body and its organs.

Epithelial Tissue: Tissue that lines the cervix and other parts of the body.

False Negative: A Pap smear or colposcopy result that mistakenly reports that no abnormal cells are identified.

False Positive: A Pap smear or colposcopy result that mistakenly reports the presence of abnormal cells.

FDA (The Food and Drug Administration): An agency of the United States Department of Health and Human Services that regulates the testing and use of drugs, devices, and tests, and evaluates new medical products for sale based on evidence of safety and efficacy.

G1 Phase (Gap 1): Phase of the cell cycle between nuclear/cytoplasmic division (M-Phase) and DNA synthesis (S-Phase). The G1 Phase is a cell-cycle checkpoint. Repairs to damaged DNA normally occur in the G1 Phase. During the G1 Phase the cell makes further decisions regarding whether to self-renew, differentiate, or die.

G2 Phase (Gap 2): Phase of the cell cycle between the S-Phase and the M-Phase. The G2 cell cycle checkpoint prevents cells from initiating mitosis when they experience DNA damage during G2, or when they progress into G2 with some unrepaired damage inflicted during previous S or G1 Phases.

General Purpose Reagents (Also known as a General Use Reagent): A chemical reagent that has general laboratory applications, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application.

Genomics: The study of all of the nucleotide sequences (including structural genes, regulatory sequences and noncoding DNA segments) in the chromosomes of an organism.

Glandular Tissue: In the cervix, tissue that produces mucus.

Gynecology: The medical field that focuses on the care of the female reproductive system.

High-Grade Squamous Intraepithelial Lesion (HSIL): A condition characterized by a number of immature cells; these cells are precancerous and, if not removed, may progress to invasive cancer.

Histo: prefix; meaning tissue.

Histochemistry: The branch of science that deals with the chemical composition of the tissues of the body.

Histology: The study of the structure, composition and function of human tissues.

Histone: Any of various simple water-soluble proteins that yield a high proportion of basic amino acids on hydrolysis and are found associated with DNA in cell nuclei.

Human Papillomavirus (HPV): Common name for a group of related viruses that may result in the presence of small warts on the woman's cervix, vagina or vulva; more than 70 different known forms of this virus exist; presence of HPV may cause no symptoms.

Immunochemistry: The application of antibodies as chemical reagents to cells or tissues.

Immunohistochemistry (IHC): The application of immunochemical techniques to histochemistry techniques.

Low-Grade Squamous Intraepithelial Lesion (LSIL): A condition characterized by a few immature cells among mostly mature cells; the abnormal cells extend through one third the thickness of the cervical skin.

IVD: In vitro diagnostic; an in vitro diagnostic is a medical test performed outside the body or a device used outside the body and is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.

Mammography: A breast examination using X-rays to detect tumors; the resulting image is called a mammogram.

Manual Screen: The microscopic review of cells by a cytotechnologist and pathologist without automated aids.

MCM 2 (Minichromosome Maintenance Proteins): Proteins that function in the early stages of DNA replication. The MCM 2 proteins are over-expressed in aberrant S-Phase induction. The over-expression of MCM proteins has been observed in dysplastic and malignant tissues, including cervical dysplasia and cervical cancer. Two MCM 2 clones are included in the BD ProEx™ C Antibody Cocktail.

Melanoma: A tumor arising from the melanocytic system of the skin and other organs. When used alone the term refers to malignant melanoma.

Microsomes: A tiny granule in the cytoplasm where protein synthesis takes place under the direction of RNA.

Mitogenic: An agent that induces mitosis.

Mitosis: The entire process of cell division, including division of the nucleus and cytoplasm.

Mutation: A change in form, quality, or some other characteristic. In genetics, mutation is a permanent transmissible change in genetic material.

Neoplasm: A new abnormal growth.

NILM: “Negative for Intraepithelial Lesion or Malignancy” - A classification assigned by a cytotechnologist that indicates no abnormal results.

Normal Pap Test: A Pap test that does not contain abnormal cells; also referred to as a negative Pap test or within normal limits (WNL).

Nuclear: Pertaining to the nucleus. Cells staining positive for aberrant S-Phase induction using
BD ProEx™ C in an ICC method has a nuclear staining pattern (brown color appears in the nucleus, not cytoplasm of the cell).

Nucleus: A large, membrane-bound, usually spherical protoplasmic structure within a living cell, containing the cell’s hereditary material and controlling the growth, metabolism and reproduction (plural is nuclei).

Oncogene: A gene found in the chromosomes of tumor cells whose interaction is associated with the initial and continuing conversion of normal cells into cancer cells.

Phagocytosis: The engulfing and destruction of particulate matter by phagocytes.

Proliferation: To grow or multiply by rapidly producing new tissue, parts, cells or offspring.

Proteins: Fundamental components of all living cells. Proteins are necessary for the proper functioning of an organism.

Proteomics: A branch of biotechnology concerned with applying the techniques of molecular biology, biochemistry, and genetics to analyzing the structure, function and interactions of the proteins produced by the genes of a particular cell, tissue, or organism, with organizing the information in databases and with applications of the data (as in medicine or biology).

Protoplasm: The living substance of a cell, including the cytoplasm and nucleus.

RNA (Ribonucleic Acid): A long linear polymer of nucleotides found in the nucleus but mainly in the cytoplasm of a cell where it is associated with microsomes; it transmits genetic information from DNA to the cytoplasm and controls certain chemical processes in the cell; ribonucleic acid is the genetic material of some viruses.

Satisfactory but Limited by (SBLB): A satisfactory cervical sample, but limited by reasons stated by the Pathologist.

Speculum: An instrument that is inserted into the vagina to enable a healthcare professional to observe the cervix and collect the Pap smear sample.

Squamous Intraepithelial Lesion (SIL): A noncancerous condition that occurs when normal cells on the cervical surface are replaced by a layer of abnormal cells; classified as high grade or low grade.

Synthesis: To put together; the composition or combination of parts or elements so as to form a whole.

TOP2A (Topoisomerase II-alpha): A nuclear enzyme involved in DNA replication. TOP2A is over-expressed in aberrant S-Phase induction. The over-expression of TOP2A has been observed in cervical disease. TOP2A is one of three antibodies included in the BD ProEx™ C Antibody Cocktail (alpha is sometimes represented by the symbol ).

Topoisomerase: An enzyme that helps to maintain the correct conformation of DNA in the cell nucleus.

Transcription: The process of constructing a messenger RNA molecule using a DNA molecule as a template with resulting transfer of genetic information to the messenger RNA.

Unsatisfactory: In cervical screening, a sample that cannot be accurately screened due to a lack of sufficient endocervical cells, or obscuring from lubricants, excessive discharge, blood, or inflammation.